.BB&T Washington Editor

The 510(k) program at FDA's Center for Devices and Radiological Health continues to serve as the lighting rod for the ages with the report that FDA will rescind the Menaflex 510(k) application by ReGen Biologics (Hackensack, New Jersey). The agency's Oct. 14 statement notes that the rescission procedure allows the device to remain on the market pending an appeal of the rescission via a regulatory hearing, but ReGen could simply decide to pull the device from the market and bring the process to an end.

FDA said in the statement that it asked ReGen “to meet with the agency to discuss the appropriate marketing pathway“ for the Menaflex as well as what kind of data the agency would need “to provide a reasonable assurance of safety and effectiveness.“

The agency notes a September 2009 internal agency report that recommended “a scientific re-evaluation of the device“ because of questions about whether “the administrative record“ supplied an adequate basis for clearance, and after its review, FDA concluded that the Menaflex “is intended to be used for different purposes and is technologically dissimilar from devices already on the market,“ a reference to devices that were used as predicates in the Menaflex application. The agency states that one difference it sees in the Menaflex is that it is “intended to stimulate the growth of new tissue to replace tissue that was surgically removed.“

FDA first cleared the device nearly two years ago after an advisory committee recommended the device be cleared the previous month, but controversy soon engulfed the application, starting with mainstream media coverage, followed by a March 6, 2009, letter from Sen. Chuck Grassley (R-Iowa) to then-acting FDA commissioner Frank Torti alleging a sometimes “cozy relationship“ between industry and FDA reviewers. Despite such allegations, the controversy stems almost entirely from congressional intervention with the FDA commissioner's office and intervention by the commissioner and the center director in the decision to clear the device. At the time, these positions were held by Andrew von Eschenbach, MD, and Dan Schultz, MD, who are both now with Greenleaf Health (Washington), a regulatory consultancy.

Among the parties who intervened on behalf of ReGen with the agency is Rep. Frank Pallone (D-New Jersey), who for the time being chairs the Energy and Commerce health subcommittee in the U.S. House of Representatives. Pallone seemed to reverse track on his position when he announced he would hold a hearing on the 510(k) process, but in a May hearing on pre-emption for PMA devices, Pallone said “I don't know when I'm going to find time“ for a hearing.

FDA convened the orthopedics and rehabilitative devices advisory committee last year to re-examine the application, but the agency was on the receiving end of a message it apparently did not like as the committee voted yet again – with a different voting membership – to recommend that the agency allow the device to stay on the market earlier this year.

ReGen's board chairman and CEO, Gerald Bisbee, Jr., PhD, had little to say about the matter in a statement released late yesterday afternoon, noting that “the company is weighing its options.“ Bisbee stated further that the Menaflex “has been approved and in use successfully in Europe for nearly 10 years with approximately 3,000 patients and there has never been a safety issue associated with the device.“

PPACA's reforms omitted in reimbursement talk

If predictability is the Holy Grail of industry, the search is presumed to be ongoing thanks to, among other things, the uncertainties engendered by the Patient Protection and Affordable Care Act of 2010 (PPACA). A session on reimbursement and price pressures held at AdvaMed 2010, sponsored by the Advanced Medical Technology Association (AdvaMed; Washington) included plenty of discussions as to how providers would be affected, but the discussions generally failed to account for two troublesome features, namely the double-counting of savings purported to stem from healthcare reform and the overhang of the sustainable growth rate (SGR) mechanism.

Karen Milgate, director of the office of policy at the center for strategic planning at the Centers for Medicare & Medicaid Services, opened her remarks by noting “there's a lot of change underway“ thanks to PPACA, but that “there are some other tools and [elements of] framework that were put in place“ prior to PPACA.

Milgate seemed wary of addressing whether the general understanding of price pressures adequately factors in all the relevant forces. Forecasts of the impact of PPACA indicate that healthcare spending in the U.S. will rise from roughly $2.5 trillion last year to about $4.7 trillion by 2019, at least according to the CMS actuarial team. However, the agency's actuaries have stated twice this year that supporters of reform are counting the savings from healthcare reform twice, applying them to both the Medicare Part A hospital trust fund and the financing of expanded enrollment under PPACA. However, no attempt has been made to account for the fact that the near-certain congressional override of SGR will cost as much as $33 billion annually, a fact even the CMS actuaries opted not to address in their annual forecast of healthcare expenditures in September.

As for price pressures, Milgate said, “I think they will be great“ in any case, but offered little more than the disclaimer that “SGR and accounting rules aside, there are some serious incentives“ for productivity. Thanks to value-based purchasing, those incentives “may be greater“ than is commonly appreciated, she said.

Joel Slackman, managing director for the Blue Cross/Blue Shield Association (BCBS; Chicago), said that from a private payer's perspective, the SGR issue and the double-counting problem tend to wash out in the face of more immediate concerns. “Its hard to imagine how price pressures – when they're already astronomical – could be higher,“ he said.

“There has been such tremendous pressure on plans“ from employers “to achieve savings quickly,“ Slackman remarked. He said employers “want to see cost savings right now. The challenge is not going to be dealing with ever greater cost pressures, but how do you meet that demand“ to “cut costs right now.“

Slackman said that the health insurance exchanges created by PPACA “will alter the landscape“ and create “very tight networks of providers“ that will influence how reimbursement is administered. “These reforms are layered on top of reforms that were underway in the private sector for several years now.“

Slackman remarked that the medical home concept pays primary care physicians (PCPs) for coordinating care, adding that the BCBS plans “have launched about 45 pilots“ for this concept that affect about 3 million patients. “There are a lot of variations across these pilots,“ he remarked, noting that some deal with multiple payers and some offer a variety of incentives for better quality of care. Some entities are “paying up front for infrastructure,“ used by providers, such as healthcare information technology, he stated.

“What they all have in common is this commitment“ to making the PCP “the hub“ of the patient's engagement with medical care, Slackman said. “Most of these pilots have been launched in the last year or so, so we don't have“ much data yet, he acknowledged. Still, “we have some early results“ suggesting that utilization and cost are sensitive to such reorganizations. In six months for one pilot, “they've started to see among patients . . . some decreases in utilization in, for example, high-cost imaging procedures,“ he said.

Slackman said the Blues are “seeing improvements in some process measures“ and in some outcomes, such as fewer admissions to hospitals for things that can be handled in ambulatory care settings. “The direction seems to be a promising one,“ although the data are preliminary, he said.

Regarding payment reforms, Slackman stated that while BCBS plans are “moving toward a more global approach, this isn't quite the same as capitation“ because of the incentives for quality and access goals. Hospitals “are under a very strong incentive“ to boost quality, he said, stating further that data from a contract rolled out several years ago by one BCBS payer allowed providers to share up to 15% of the savings engendered by care improvements, but “they have to eat 15%“ if they don't hit the measures, he remarked. These measures include, for instance, clinical processes for treatment of acute myocardial infarcts.

Slackman said the Blues have several concerns about healthcare reform, including that “we're very concerned about the ultimate trajectory of accountable care organizations.“ He posed the question, “will CMS inadvertently give ACOs undue market concentration and consolidation, which would lead to higher prices?“ He noted that health insurance exchanges “let states allow all health plans that meet standards to participate,“ but he spoke as if to convey the idea that the consumer is now king where healthcare is concerned. Consumer choice, he said, “is going to have a huge effect on the world in which we all operate.“

New Delhi aims to put India on med-tech map

Inhabitants of the med-tech industry already know they have fans among governments of nations other than the U.S. – thanks in no small part to the higher-than-average wages enjoyed by employees of the industry – but a session held on the last day of AdvaMed 2010, hosted by the Advanced Medical Technology Association (AdvaMed; Washington) made clear that the colossus of the subcontinent has now declared itself a player in the global med-tech sweepstakes.

India's Central Drugs Standards Control Organization (CDSCO) has been fairly busy lately with guidances on a variety of issues, including device clinical trials and registration requirements, but it appears that this is just the tip of the iceberg where New Delhi's interest in med-tech is concerned, even though there is not as yet a full-blown regulatory framework specifically for medical devices. That, however, is about to change.

Arun Jha, the joint secretary of the Department of Pharmaceuticals of the government of India, said at the AdvaMed session that New Delhi is keenly interested in developing a med-tech sector in India, which he reminded attendees has a “middle class of 300 million“ and which has “great expectations“ of healthcare.

“India's medical device regulatory sector is evolving,“ Jha said, and is moving in the direction of the standards promulgated by the Global Harmonization Task Force, which employs a four-tier device classification scheme for both therapeutic and diagnostic devices. “We have a goal of facilitating and promoting this sector,“ he said, adding that the government also seeks “to make healthcare more accessible and affordable“ even as it seeks “to provide the ecosystem for growth“ of its native med-tech industry.

Jha noted that the government in India has an established public-sector pharmaceutical research arm, the National Institute for Pharmaceutical Development and Research (NIPER) in Nagar, but he stated “we have decided to have a national center for medical devices,“ a med-tech cluster to be located in the state of Gujarat, which is on the other side of the country from Nagar, bordering Pakistan and facing the Arabian Sea.

Gugarat will be the home for the Greenfield Medical Devices and Equipment Park, which is under construction and is financed by a sum of more than 300 million rupees, the rough equivalent of $60 million. Jha said Greenfield is “an attempt to make available ... in one single location“ a series of facilities for research into various types of medical devices. It will be a state of the art facility, he said, and will constitute “an excellent opportunity for manufacturers“ to develop products without having to foot the bill for the square footage needed for their R&D work.

Greenfield “would not only enable them to cater to the growing local market, but also to fulfill the potential of the region,“ Jha said, by which he meant the Asian subcontinent as well as adjacent parts of the Middle East, and Southeast Asia. One of the plants at Greenfield will offer 20,000 square feet for research into disposable devices, but other divisions will also be in operation once the center is fully operational.

“We are also proposing to have a National Center for Medical Devices“ (NCMD) as part of NIPER, which will be located Ahemadabad, also found in Gugarat. This center will help develop good manufacturing practices and other quality control standards, dealing with time-consuming but standard issues such as sterilization, process validation and so on. “The center is intended to be complementary to the Greenfield Park,“ Jha stated, adding that it “will focus on product development and assessment.“

Jha acknowledged that devices are currently scrutinized under regulations written for pharmaceuticals, so the emphasis at NCMD is on training for both good manufacturing practices and for “officials conducting medical device inspections.“ However, resources for this training are an issue at present. New Delhi is working on developing standards for device testing, he said, but the government also has to put together some testing facilities capable of handling state-of-the-art device technology.

“Medical device training centers are being planned to provide“ support to regulatory staff, Jha said, but the effort is still a nascent one. Jha reiterated that NIPER is “fast working to align“ its regulatory scheme with the GHTF format and that “very soon, we'll have a fully harmonized regulatory system.“

Jha stated that tax policy is also under the microscope. “Various measures have been undertaken to further rationalize taxes and duties to encourage further investment“ in med-tech, and uniform duties for imports are down to 5%, he said, making note of other adjustments to various tax policies designed to stimulate activity in this part of India's economy.

Jha was intent on conveying an upbeat message about the future of med-tech in India, telling device executives in attendance, “we believe the device sector holds tremendous promise for India,“ but also that India “holds tremendous promise for the global economy“ thanks to its location in the world's most populous continent and its commitment to med-tech development.

FDA publishes 510(k) guidance for FFDM

After four contentious years, FDA has finally published a 510(k) guidance for full-field digital mammography (FFDM) systems, capping a process that has demonstrably tested the patience of industry and academe, and which was riddled by dissent within the agency, largely through the efforts of two FDA employees who contacted the White House and Congress over what they saw as an illicit attempt by senior FDA management to overrule the views of reviewers at the agency.

In a Nov. 4 statement at the FDA website, the agency posted a statement noting that “digital mammography has been well-validated in scientific studies involving tens of thousands of patients,“ a nod to several studies, including the DMIST (Digital Mammographic Imaging Screening Trial) study, which enrolled nearly 50,000 patients to compare several FFDM systems to conventional X-ray film mammography.

The FDA statement goes on to note that “the benefits and risks of digital versus film mammography have also been well-described to physicians,“ hence the reclassification from class III to class II. Jeff Shuren, MD, director of the Center for Devices and Radiological Health at FDA, said in the statement that the decision “is consistent with feedback we've received from public discussions with appropriate medical and scientific experts as well as our stronger understanding of how these systems work.“

FDA convened a hearing of the radiological devices advisory panel more than four years ago to review the reclassification, which led to a recommendation that FDA drop the PMA requirement for such devices, but the process of reclassification dragged on in what had become a conspicuous bone of contention between FDA on the one hand and industry and academic experts on the other.

Among the critics of FDA's reticence to publish the special controls guidance was Etta Pisano, MD, chief of breast imaging at the University of North Carolina (Chapel Hill), who appeared at the May 2006 hearing and who served as the principal investigator for DMIST. Industry is expected to criticize the four-year lag on the guidance, but Pisano's standing in academe meant that her criticism were probably sharply felt at the agency over the problem.

In a follow-up hearing of the radiological devices advisory committee last year, Pisano argued that DMIST “found significantly improved sensitivity“ compared to film systems and said “the time for skepticism has passed.“ She stated further that FDA “was there for the design of DMIST“ and that any clinical study comparing digital to film that also incurred a double exposure to X-radiation would be unethical.

Pisano told BB&T in a brief e-mailed statement that the news is “overdue but incredibly welcome news for women and we doctors working to diagnose breast cancer. Hooray for this action today by the FDA! I'm thrilled this has finally happened!“

Much of the blame for the dragged-out process has been attributed to Robert Smith, MD, who left the agency earlier this year after two appearances at FDA advisory committee hearings not in his capacity as a reviewer, but as a citizen. His views on the applicability of special controls for FFDMs were not universally held at FDA, however.

Bob Phillips, PhD, who was the chief of the radiology devices branch at the time of the 2006 hearings, said during that hearing that “our understanding of FFDM technology has improved to the point where we can develop appropriate special controls“ that will aid in determinations of substantial equivalence.

As for Smith, Pisano told BB&T in an interview earlier this year that she found his insistence that clinical data are necessary to establish substantial equivalence “strange,“ adding that she found his views suggestive that Smith was “not experienced in mammography or breast imaging.“

Bob Rusk, president of Giotto USA (Wichita, Kansas), who spoke at the FFDM hearings, told BB&T in an interview that “the publishing of the final rules is long overdue,“ although he argued that the rules “are little different from what they proposed in 2006.“